FDA Issues Three Final FSMA Rulings

On Nov 13, the Food and Drug Administration, Washington, released three final rules under the Food Safety Modernization Act. The rules include the Produce Safety Final Rule, the Foreign Supplier Verification Programs Final Rule and the Accredited Third-Party Certification Final Rule. The agency also released an environmental impact statement regarding the Produce Safety Final Rule.

The rules will help produce farmers and food importers take steps to prevent food safety problems before they occur.

Proposed in July, 2013, the Accredited Third-Party Certification Rule establishes a voluntary program for the accreditation of third-party certification bodies to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. These requirements will help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program.

Foreign entities may use certifications for two purposes: Certifications may be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food. To prevent potentially harmful food from reaching U.S. consumers, the FDA can also require, in specific circumstances, that a food offered for import be accompanied by a certification from an accredited third-party certification body.

The Produce Safety rule, first proposed in January 2013, establishes for the first time, science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The FDA issued a supplemental notice of proposed rulemaking in September 2014. The proposed revisions were designed to make the originally proposed rule more practical, flexible and effective.

The final rule combines the original proposal and revisions outlined in the supplemental proposal, with additional changes. Revised in the final Preventive Controls for Human Food Rule was the definition of "farm" and related terms rule, and the same definitions of those terms are used in this rule to establish produce safety standards. Operations whose only activities are within the farm definition are not required to register with FDA as food facilities and thus are not subject to the preventive controls regulations.

Now final, the Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals requires compliance dates for some businesses to begin in 18 months. The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders. The FDA first proposed this rule in July 2013.

After input received during the comment period and numerous other engagements, the FDA issued a supplemental notice of proposed rulemaking in September 2014. The proposed revisions included providing importers flexibility in determining appropriate verification measures based on food and supplier risks, while acknowledging the greater risk to public health posed by the most serious hazards in foods.

The final rule has elements of both the original and supplemental proposals, with the addition of greater flexibility in meeting certain requirements to better reflect modern supply and distribution chains. For example, importers can meet key Foreign Supplier Verification Programs (FSVP) obligations by relying on analyses, evaluations and activities performed by other entities in certain circumstances, as long as those importers review and assess the corresponding documentation.

The FDA is responsible for ensuring that importers meet the FSVP requirements, and will also provide guidance, outreach and training.